Z-0296-2021Class II

LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

Name: Z-0296-2021 LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Creator: Thread Counsel Inc Dba Laws of Motion
Published: 2020-09-17
License: https://open.fda.gov/license/

Thread Counsel Inc dba Laws of Motion / initiated 2020-09-17 / Open, Classified / root cause: manufacturing process

FDA source

THREAD COUNSEL INC DBA LAWS OF MOTION began a recall of LOM Disposable Surgical Gowns/Medical Gowns, Single-Use on 2020-09-17. FDA classified it as Class II and gives the reason as "Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0296-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-17
Posted: 2020-10-26
Recalling firm: Thread Counsel Inc dba Laws of Motion
Product: LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Product code: FYA Gown, Surgical
Reason for recall: Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On September 17, 2020, the firm sent an Urgent Medical Device Recall letter to New York State. The customer was informed of the product deficiencies. The customer was asked to take the following actions: 1. Immediately identify and quarantine all Affected Gowns at your site. As per the FDA Release, dated August 28, 2020, medical personnel should not use or further distribute LOMs gowns until the FDA completes its investigation (Attachment A). Therefore, do not distribute or use the Affected Gowns. 2. Complete the attached Return Recall Response Form to confirm the number of Affected Gowns remaining in your inventory, as well as the status of the remaining 505,220 gowns (Remaining Gowns) which are no longer in your possession (i.e., where they were distributed, if they were used, etc.). Please send the completed form by email to Marissa Custren, Head of Logistics, Laws of Motion PPE at [email protected] or fax it to the attention of Lynn Neils, Esq. at Baker Botts LLP at (212) 259-2510. 3. Upon receiving the completed Response Form, we will contact you to arrange for the return of the Affected Gowns. You may also contact outside counsel, Drew Chapman (212) 408- 2515, or Lynn Neils, (212) 408-2510, with Baker Botts LLP, to arrange for delivery or pick-up of the Affected Gowns. 4. Notify all customers/medical facilities/providers who may have received this product of this recall. Alternately, you may provide LOM with a list of your customers and LOM will notify these accounts on your behalf. 5. Ensure that all impacted employees at your site have been informed of this recall.
Quantity in commerce: 2.4 million
Distribution: Distributed to accounts in New York
Product codes and lots: Lots 1 -47

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0296-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0296-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-04	2020-10-25

Product code FYA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)